Genedrive PLC POC kit submitted for CE-IVD certification (7987T)
29 November 2021 - 6:00PM
UK Regulatory
TIDMGDR
RNS Number : 7987T
Genedrive PLC
29 November 2021
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION AS DEFINED IN
REGULATION (EU) NO 596/2014 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL OF 16 APRIL 2014 ON MARKET ABUSE (MARKET ABUSE REGULATION)
AS RETAINED AS PART OF UK LAW BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018 AS AMENDED.
genedrive plc
("genedrive" or the "Company")
Point-of-care Genedrive(R) COV19-ID submitted for CE-IVD
certification
Sets new benchmark in speed, accuracy and ease of use
genedrive plc (LSE: GDR), the near patient molecular diagnostics
company, announces that it has submitted its new rapid Point of
Care molecular test for SARS-CoV-2 detection for CE-IVD
certification under the European Communities Council Directive
98/79. The Genedrive(R) COV19-ID kit offers a step change in rapid
molecular testing, delivering positive results as quickly as 7.5
minutes and negative results at 17 minutes.
Following self-certification, the Genedrive(R) COV19-ID Kit has
been passed to genedrive's Authorised Representative for formal
registration, a process expected to take ten working days to
complete, following which the product can be made available
commercially in the European Union. In parallel, the product is
being provided for review and evaluation to a range of potential
commercial partners who have actively expressed interest in the
product.
The Genedrive(R) COV19-ID Kit is based on the rapid molecular
technique Reverse-Transcription Loop Mediated Isothermal
Amplification (RT-LAMP). The test has an analytical Limit of
Detection (LoD) of 52 copies per test. It is performed directly
from a nasal swab using the Genedrive(R) Point of Care platform.
The assay targets the ORF1ab and N genes of the SARS-CoV-2 genome,
adding robustness against emerging SARS-CoV-2 variants which
generally impact assays targeted against the S-gene (Spike protein)
. In the case of the new B.1.1.529 South African variant ("
Omicron") , while less than 100 genetic sequences had been made
publicly available at the time of CE submission, none of them had
mutations affecting the assay design of the Genedrive(R) COV19-ID
Kit.
Sensitivity and specificity was 98.2% and 98.9% respectively in
a clinical validation cohort of 149 samples (58 positives at
greater than 500 copies per ml) which were referenced against the
Thermo Fisher TaqPath COVID-19 RT-PCR test. The Genedrive(R)
COV19-ID molecular test offers several orders of magnitude
improvement in sensitivity compared to antigen lateral flow
devices, which range widely in sensitivity, from 0.1 million copies
per ml analytically(1) and from >1 million copies per ml under
clinical evaluation(2) . The clinical cohort included five
confirmed SARS-COV2 Delta variants, which were all detected by the
Genedrive(R) COV19-ID test. The sensitivity and specificity of the
assay on the entire cohort met the current requirements of the UK's
MHRA Target Product Profile for a SARS-CoV-2 Point of Care
molecular diagnostic test.
Information about the Genedrive(R) instrument and the new
Genedrive(R) COV19-ID Kit can be found at
http://www.genedrive.com/assays/cov19-id-assay.php
The Company's initial commercial focus is the European Union,
utilising the regulatory clearance of CE marking, and will be
followed by the UK. The registration processes in the UK require a
larger sample set than for CE marking and submission under CTDA
legislation. The Company is actively recruiting patient samples for
these expanded requirements, which is proceeding well.
David Budd, CEO of genedrive plc, said: "I am delighted to say
that development work from the Company has resulted in designing
and delivering a product with excellent performance specifications
and a speed to result that is a new benchmark. The new Genedrive
(R) COV19-ID Kit combines the speed and ease of lateral flow
testing with molecular level accuracy in a low cost and portable
device. We are now able to progress the commercial evaluations of
the product to selected partners and given its performance in our
studies, we believe there remain substantial market opportunities
that can be targeted. As recent news of the Omicron variant
demonstrates, COVID-19 remains a significant issue in global health
and thus rapid and accurate testing will remain a critical tool in
managing the spread of the virus."
The Company is seeking commercial partners in some specific EU
countries. Potential partners can register their interest via
info@genedrive.com
1 - Cubas--Atienzar A. et al., Scientific Reports (2021)
11:18313
2 - García-Fiñana, A. et al. BMJ 2021;374:n1637 | doi:
10.1136/bmj.n1637
For further details please contact:
genedrive plc
David Budd: CEO / Matthew Fowler: CFO +44 (0)161 989 0245
Peel Hunt LLP (Nominated Adviser and
Joint Broker) +44 (0)20 7418 8900
James Steel
finnCap (Joint Broker) +44 (0)20 7220 0500
Geoff Nash / Kate Bannatyne / Alice
Lane
Walbrook PR Ltd (Media Relations +44 (0)20 7933 8780 or genedrive@walbrookpr.com
& In vestor Relations)
+44 (0)7980 541 893 / +44 (0)7876
Paul McManus / Anna Dunphy 741 001
About genedrive plc ( http://www.genedriveplc.com )
genedrive plc is a molecular diagnostics company developing and
commercialising a low cost, rapid, versatile, simple to use and
robust point of need molecular diagnostics platform for the
diagnosis of infectious diseases and for use in patient
stratification (genotyping), pathogen detection and other
indications. The Company has assays on market for the detection of
HCV and certain military biological targets. The Company recently
released a high throughput SARS-CoV-2 assay and has a point of care
version of the SARS-Cov-2 test due on market during 2021.
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